United States District Court, D. Delaware
COSMO TECHNOLOGIES LIMITED, VALEANT PHARMACEUTICALS INTERNATIONAL, and VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L., Plaintiffs,
LUPIN LTD. and LUPIN PHARMACEUTICALS, INC., Defendants. COSMO TECHNOLOGIES LIMITED, VALEANT PHARMACEUTICALS INTERNATIONAL, and VALEANT PHARMACEUTICALS LUXEMBOURG S.A R.L., Plaintiffs,
MYLAN PHARMACEUTICALS INC., Defendant.
LEONARD P. STARK UNITED STATES DISTRICT JUDGE.
Wilmington this 14th day of
September, 2017, having reviewed the parties'
briefs on Defendants' motion to strike paragraph 48 of
Dr. Atwood's expert report served to Lupin and paragraph
49 of Dr. Atwood's expert report served to Mylan (D.I.
155, 158, 159), 
HEREBY ORDERED that:
Defendants' motion to strike (C.A. No. 15-669-LPS D.I.
156; C.A. No. 16-152-LPSD.I. 107) is DENIED.
Infringement contentions serve the purpose of providing
notice to Defendants of Plaintiffs' infringement theories
early in the case. See Intellectual Ventures I LLC v.
AT&T Mobility LLC, 2017 WL 658469, at *2 (D. Del.
Feb. 14, 2017). Generally, "infringement contentions
must set forth particular theories of infringement with
sufficient specificity to provide defendants with notice of
infringement beyond that which is provided by the mere
language of the patents themselves." Trading Techs.
Int'l, Inc. v. CQG, Inc., 2014 WL 4477932, at *2
(N.D. 111. Sept. 10, 2014). As such, infringement contentions
are considered to be "initial disclosures" under
Federal Rule of Civil Procedure 26(a). See United
States District Court for the District of Delaware,
Default Standard for Discovery § 4(a). A
failure to make a disclosure under Rule 26(a) "may lead
to exclusion of the materials in question" under Rule
37(c)(1). Lambda Optical Sols., LLC v. Alcatel-Lucent USA
Inc., 2013 WL 1776104, at *2 (D. Del. Apr. 17, 2013). In
relevant part, Rule 37(c)(1) provides that "[i]f a party
fails to provide information ... as required by Rule 26(a). .
., the party is not allowed to use that information ... to
supply evidence on a motion, at a hearing, or at a trial,
unless the failure was substantially justified or is
determining whether to exclude evidence such as an expert
report, the Court may consider: (1) the importance of the
information withheld; (2) the prejudice or surprise to the
party against whom the evidence is offered; (3) the
likelihood of disruption of the trial; (4) the possibility of
curing the prejudice; (5) the explanation for the failure to
disclose; and (6) the presence of bad faith or willfulness in
not disclosing the evidence (the "Pennypack
factors"). See Konstantopoulos v. Westvaco
Corp., 112F.3d710, 719 (3d Cir. 1997) (citing Meyers
v. Pennypack Woods Home Ownership Ass % 559 F.2d 894,
904-05 (3d Cir. 1977)). Generally, "exclusion of
critical evidence is an extreme sanction, not normally to be
imposed absent a showing of willful deception or flagrant
disregard of a court order by the proponent of the
evidence." In rePaoliR.IL YardPCB
Litig., 35 F.3d 717, 791-92 (3d Cir. 1994) (internal
quotation marks omitted). The determination of whether to
exclude evidence is committed to the discretion of the Court.
See Id. at 749.
Defendants' motion concerns Plaintiffs' theory for
how the accused products meet the claims'
"macroscopically homogenous structure" limitation.
Plaintiffs' initial contentions, served before claim
construction in this case,  focused on the theory that
Defendants' manufacturing processes and quality-control
assurances result in tablets that meet this limitation.
(See D.I. 155 Ex. 3 at Appx. B at 1-2; Ex. 4 at
Appx. E at 1-2) On March 15, 2017, the Court construed
"macroscopically homogenous structure" - consistent
with its construction in earlier, "first-wave"
cases - to mean "a composition of uniform structure
throughout, as observed by the naked eye." (D.I. 119 at
10) Plaintiffs did not thereafter supplement their
infringement contentions to include reference to observation
by the naked eye. However, Dr. Atwood, Plaintiffs'
expert, nevertheless conducted visual inspections of the
accused products and reported his observations in his
reports. Defendants contend that these analyses introduce a
new infringement theory.
Court does not agree with Defendants that Dr. Atwood's
expert reports, including his visual observations, go beyond
what Defendants were fairly on notice of, given
Plaintiffs' initial contentions as well as the course of
these cases. Plaintiffs' infringement theory has hot
changed, and the bulk of Dr. Atwood's expert opinions
analyzes Defendants' AND A filings, including the
manufacturing processes and quality-control testing
referenced in the infringement contentions. At most, Dr.
Atwood's visual examination is additional evidence that
purports to support their previously-disclosed infringement
theory. That is not sufficient reason to strike the disputed
paragraphs. See, e.g., Mobile Telecomms. Techs., LLC v.
Blackberry Corp., 2016 WL 2907735, at *2 (N.D. Tex. May
timing of Plaintiffs' "new" infringement
contentions (to the extent they are viewed as new) is also,
under the circumstances, "substantially justified."
Trial in the first-wave cases concluded on May 23, 2017, with
a finding by the Court that Plaintiffs had failed to prove
that other Defendants' generic products infringed, in
part based on the lack of evidence of the
"macroscopically homogeneous" claim limitation, due
to the absence of an expert opinion based on visual
observation by the naked eye. (See C.A. No.
15-164-LPS D.I. 243 at 64) It was logical and reasonable for
Plaintiffs, when they filed their opening expert reports in
the above-captioned cases about a week later, on June 1, to
include the expert's opinions regarding his visual
inspection of Defendants' proposed generic products.
decision not to strike the challenged paragraphs is confirmed
by application of the Pennypack factors. The
portions of Dr. Atwood's opinions that Defendants move to
strike are in his opening expert reports. Accordingly,
Defendants' experts had the opportunity to - and did, in
fact - respond to Dr. Atwood's naked-eye observations in
their rebuttal reports. (See D.I. 158 Ex. A at
¶¶ 68-78; Ex. B at ¶¶ 46-49, 63)
Defendants received image files of photographs that Dr.
Atwood took to memorialize his visual observations, and
Defendants have (or have had) the opportunity to depose Dr.
Atwood about these observations. Further, as made clear
during the first-wave cases, Dr. Atwood's naked-eye
observations of the AND A products may be critical evidence
for infringement purposes. There is no indication that
Plaintiffs have acted willfully or flagrantly disregarded any
Court order. Allowing the evidence to remain part of the case
also does not threaten the trial date (although, as explained
below, the Court is going to need to alter the trial date for
for the reasons given above, Defendants' motion to strike
alluded to above, the Court finds it necessary, for reasons
unrelated to the dispute addressed herein and arising from
other commitments, to move the trial date in these cases.
Trial is currently scheduled to be held between October 30
and November 3. The Court is no longer available on October
30-November 1 and is scheduled to be in a criminal jury trial
on November 2 and 3. The Court is also scheduled to be in
that criminal jury trial all of the following week, November
6-10, and also has another civil bench trial scheduled during
that week as well.
light of this situation, the Court is considering at least
the following options:
A. Trial could begin November 2, and continue for as many
days as needed (potentially to include Saturday November 4),
to be held between 4:00 p.m. and 7:00 p.m. on days that the
criminal trial is underway, until the criminal trial
concludes, at ...